CN111166837B - Traditional Chinese medicine composition for treating colorectal cancer and application thereof - Google Patents
Traditional Chinese medicine composition for treating colorectal cancer and application thereof Download PDFInfo
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Abstract
The invention relates to a traditional Chinese medicine composition for treating colorectal cancer and application thereof, wherein the traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 25-35 parts of raw astragalus root, 12-18 parts of sophora flavescens, 14-16 parts of codonopsis pilosula, 15-20 parts of fried bighead atractylodes rhizome, 15-25 parts of white poria, 25-35 parts of fried coix seed, 25-35 parts of spreading hedyotis herb, 1-3 parts of dragon's bone, 1-3 parts of centipede and 3-9 parts of liquorice. The traditional Chinese medicine composition has the advantages of strict formula, proper selected materials, reasonable compatibility and simple and specific medicine, and has the effects of tonifying qi and spleen, dissipating stagnation and dredging collaterals. Animal experiments and clinical experiments show that the composition can obviously inhibit tumor growth, improve survival rate, improve health condition of patients and improve life quality of the patients when used for treating colorectal cancer, and has excellent effect.
Description
Technical Field
The invention relates to the technical field of traditional Chinese medicine compositions, in particular to a traditional Chinese medicine composition for treating colorectal cancer and application thereof.
Background
Colorectal cancer (CRC) is the most common malignancy of the digestive tract in the clinic. The global cancer statistics in 2018 show that colorectal cancer is the third cancer with the third incidence and the second cancer with the second mortality in the world. The mortality rate of colorectal cancer in China is in a descending trend in nearly thirty years, but the morbidity rate is rapidly increased and the trend of the rejuvenation is more obvious. Colorectal cancer is occult, early symptoms are not obvious, diagnosis is mostly in the middle and late stages, about 15 to 25 percent of patients are diagnosed with distant metastasis, and in addition, 18 to 25 percent of patients are distant metastasis within 5 years after diagnosis. Currently, therapeutic measures for colorectal cancer include: surgery, chemotherapy, radiation therapy, targeted therapy, and immunotherapy.
At present, the traditional Chinese medicine treatment is one of important means for the comprehensive treatment of colorectal cancer. The Huangdi's classic in Qin Han dynasty has been recorded with the names of "intestinal wind", "intestinal mass" and "ovarian cell", and the manifestations of these diseases are highly similar to those of large intestine cancer. According to the traditional Chinese medicine, the colorectal cancer is mainly caused by deficiency of qi of spleen and stomach, excessive diet, overeating of fat, sweet, thick and greasy and dirty products, weakness of spleen and stomach, vegetarian diet stagnation, endogenous dampness, heat generation due to stagnation, dreg descending, large intestine transmission dysfunction, pathogenic qi accumulation, chronic disease damage to kidney, spleen and kidney deficiency, healthy qi deficiency, excessive pathogenic factors, cancer toxin retention and collateral obstruction. Therefore, the large intestine cancer is located in the intestine and relates to the spleen and the kidney, the pathogenesis is the deficiency of the spleen and the kidney as the principal factor, the damp-heat stasis toxin as the secondary factor, the deficiency of the principal factor as the secondary factor and the intermingled deficiency and excess.
The theory of collateral diseases is one of the important basic pathogenesis of traditional Chinese medicine, is widely applied to clinical diagnosis and treatment of tumor diseases in recent years, and has theoretical guiding significance for research and treatment of mechanisms such as colorectal cancer generation and development, metastasis and the like. In the cloud of Huangdi's internal classic, the five zang organs are caused by the flow of blood and qi through the meridians and marrow, disharmony of blood and qi, and various diseases. Patients with advanced colorectal cancer mostly present with weakness, limp limbs, lack of appetite, shortness of breath, no speaking, dark tongue with yellow or white greasy coating and syndrome type with spleen deficiency and obstruction of collaterals, so the spleen-tonifying and collaterals-dredging are the main treatment principle. As digestive endoscopy is not completely popularized in China, and early symptoms of colorectal cancer are not obvious, most patients consume qi and blood after the late period of the disease is discovered, the qi is blood stagnation, water retention is accumulated in intestinal tracts, and blood stasis and phlegm are coagulated into tumor masses. The pathological mechanism of obstruction of collaterals and disturbance of qi and blood circulation of patients with colorectal cancer is met by the symptoms that qi stagnation occurs in the channels, blood damages collaterals due to long-term illness occurs and qi stagnation occurs in collaterals, and qi and blood stagnation occurs in the abdomen due to long-term pain. The spleen-tonifying compound combined chemotherapy can improve clinical symptoms of intestinal cancer patients, improve life quality, effectively improve 5-year survival rate of intestinal cancer postoperative patients, and reduce 1-2-year transfer rate.
The traditional Chinese medicine has abundant diagnosis and treatment experiences in clinical diagnosis and treatment of colorectal cancer, and plays an important role in comprehensive treatment of the colorectal cancer through unique treatment methods and concepts of integral combination of ginseng and treatment based on syndrome differentiation. A plurality of clinical tests and retrospective researches prove that the traditional Chinese medicine can improve the prognosis of patients after being combined with chemotherapy, targeted drugs and the like to treat colorectal cancer patients, not only can reduce the toxic and side effects of the chemotherapy, but also can kill tumor cells in cooperation with the chemotherapy drugs, play the curative effects of sensitivity enhancement and attenuation, improve the curative effect and reduce the recurrence and transfer risks of colorectal cancer. In addition, the traditional Chinese medicine can greatly improve symptoms of diarrhea, weakness and the like of intestinal cancer patients and improve the life quality.
The clinical observation of the spleen-tonifying and tumor-eliminating prescription for preventing postoperative recurrence and metastasis of colorectal cancer (horse courser, royal Ye, Chua Difang, etc.; Shanghai J.Med., 2005, stage 01) observed the curative effects of the spleen-tonifying and tumor-eliminating prescription in combination with chemotherapy for preventing postoperative recurrence and metastasis of colorectal cancer. The 53 cases were randomized into 28 treatment groups and 25 control groups. The control group is only used for chemotherapy, and the treatment group is taken with the spleen-invigorating and tumor-eliminating prescription for 6 months simultaneously with the chemotherapy. The result shows that the recurrence rate of metastasis of the treatment group is less than that of the control group (P <0.05), the improvement of the life quality of the treatment group is better than that of the control group (P <0.05), and the treatment group shows that the spleen-invigorating and tumor-eliminating prescription (codonopsis pilosula 15g, astragalus root 30g, bighead atractylodes rhizome 15g, fiveleaf akebia fruit 15g, poria cocos 30g, coix seed 30g, chinaroot greenbrier rhizome 30g, curcuma zedoary 15g, rhizoma smilacis glabrae 30g, vitis amurensis 30g, centipede 2g, dragon's bone 6g, calcined corrugated rhizome 30g, radix semiaquilegiae 12g, rhizoma polygonati 30g, dogwood fruit 15g, herba epimedii 15g and semen cuscutae 15g can reduce recurrence and metastasis after colorectal cancer reduction and chemotherapy along with symptoms), and the effect is better than that of simple chemotherapy. The patent application (CN105456949A, published 2016.04.06) previously filed by the applicant discloses a traditional Chinese medicine composition for treating colorectal cancer and application thereof, wherein the traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 9-18 parts of codonopsis pilosula, 20-40 parts of astragalus membranaceus, 9-27 parts of fried bighead atractylodes rhizome, 10-20 parts of epimedium herb, 20-40 parts of fried rice kernels, 5-15 parts of pinellia ternate, 10-20 parts of dandelion, 10-20 parts of raw oyster, 10-20 parts of curcuma zedoary and 20-40 parts of Chinese actinidia root. Clinical experiments show that the traditional Chinese medicine composition can effectively prolong the life cycle of a patient with colorectal cancer, improve the life quality and enhance the recent curative effect.
After further research by the applicant, the prescription is adjusted to obtain the traditional Chinese medicine composition. Compared with the prior art, the traditional Chinese medicine composition has better curative effect and also shows remarkable advantages compared with other traditional Chinese medicine compositions for treating colorectal cancer at the present stage.
Disclosure of Invention
The invention aims to provide a traditional Chinese medicine composition for treating colorectal cancer aiming at the defects in the prior art.
The invention further aims to provide application of the traditional Chinese medicine composition.
The other purpose of the invention is to provide a preparation method of the traditional Chinese medicine composition.
In order to achieve the first purpose, the invention adopts the technical scheme that:
a traditional Chinese medicine composition for treating colorectal cancer is prepared from the following raw material medicines in parts by weight: 25-35 parts of raw astragalus root, 12-18 parts of sophora flavescens, 14-16 parts of codonopsis pilosula, 15-20 parts of fried bighead atractylodes rhizome, 15-25 parts of white poria, 25-35 parts of fried coix seed, 25-35 parts of spreading hedyotis herb, 1-3 parts of dragon's bone, 1-3 parts of centipede and 3-9 parts of liquorice.
As a preferred example of the invention, the traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 28-32 parts of raw astragalus, 14-16 parts of radix sophorae flavescentis, 14-16 parts of codonopsis pilosula, 16-20 parts of fried bighead atractylodes rhizome, 17-22 parts of white poria, 28-32 parts of fried coix seed, 28-32 parts of spreading hedyotis herb, 1-3 parts of dragon's bone, 1-3 parts of centipede and 3-6 parts of liquorice.
More preferably, the traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 30 parts of raw astragalus, 15 parts of radix sophorae flavescentis, 15 parts of codonopsis pilosula, 18 parts of fried bighead atractylodes rhizome, 18 parts of white poria, 30 parts of fried semen coicis, 30 parts of oldenlandia diffusa, 3 parts of longhairy antenoron herb, 1 part of centipede and 6 parts of liquorice.
As another preferable example of the present invention, the dosage form of the Chinese medicinal composition is decoction, capsule, granule, tablet or mixture.
As another preferred example of the present invention, the Chinese medicine composition further comprises a pharmaceutically acceptable carrier.
In order to achieve the second object, the invention adopts the technical scheme that:
the application of the traditional Chinese medicine composition in preparing a medicine for treating colorectal cancer.
In a preferred embodiment of the present invention, the colon cancer is postoperative colon cancer.
In order to achieve the third object, the invention adopts the technical scheme that:
a method for preparing the traditional Chinese medicine composition.
Herein, the raw astragalus root is a slice of dried astragalus root. The rhizoma Atractylodis Macrocephalae preparata process comprises scattering honey-fried bran into a hot pot, adding rhizoma Atractylodis Macrocephalae slices when smoking, parching to brown, and removing honey-fried bran 10kg per 100kg of rhizoma Atractylodis slices. The parched Coicis semen is prepared by collecting clean Coicis semen, placing in a parching container, heating with slow fire, and parching to slight yellow surface.
By "pharmaceutically acceptable" is meant a material that is not biologically or otherwise undesirable, i.e., the material may be administered to an individual without causing any undesirable biological effects or interacting in a deleterious manner with any of the components of a composition in which the material is contained.
The "carrier", also referred to as "excipient", includes any commonly used excipient in pharmacy and should be selected based on compatibility and release properties of the dosage form. Exemplary carrier materials include, for example, emulsifiers, binders, suspending agents, disintegrants, fillers, surfactants, solubilizers, stabilizers, lubricants, wetting agents, diluents, and the like.
The "pharmaceutically acceptable carrier" may include, but is not limited to, gum arabic, gelatin, colloidal silicon dioxide, calcium glycerophosphate, calcium lactate, dextrin-maltose complexing agent, glycerin, magnesium silicate, sodium caseinate, soybean lecithin, sodium chloride, tricalcium phosphate, dipotassium hydrogen phosphate, sodium stearoyl lactylate, carrageenan, monoglyceride, diglyceride, pregelatinized starch, and the like.
In addition to the above-mentioned dosage forms, the Chinese medicinal composition of the present invention can be prepared into various dosage forms which are conventional in the art, preferably in the form of solid, semisolid or liquid, and can be an aqueous solution, a nonaqueous solution or a suspension, more preferably decoction, granules, tablets, capsules, pills, oral liquid or powder, etc. The administration route of the traditional Chinese medicine composition is preferably oral administration.
The traditional Chinese medicine composition can be prepared into various dosage forms by adopting a conventional method, including but not limited to decoction, water extraction, alcohol extraction, solvent immersion, reflux extraction, microwave extraction, solvent extraction and the like.
The invention has the advantages that:
according to the clinical symptoms of colorectal cancer patients and deep analysis of etiology and pathogenesis of colorectal cancer, the invention further studies the drug properties and interrelation of each traditional Chinese medicine, and selects the formula of the traditional Chinese medicines of raw astragalus (ASTRAGALI RADIX), RADIX SOPHORAE FLAVESCENTIS (Sophorae FLAVESCENTIS RADIX), RADIX codonopsitis (Codonopsis RADIX), fried RHIZOMA ATRACTYLODIS MACROCEPHALAE (Atractylodes macrocephala), white PORIA (PORIA), fried SEMEN COICIS (Coici SEMEN), oldenlandia diffusa (HERBA HEDYOTIS), Gekko (Gekko), centipede (Scopolendra), and licorice (Glycyrrhizae IX RHIMA). Radix astragali has sweet taste and mild nature, enters lung and spleen channels, has effects of invigorating qi, invigorating yang, inducing diuresis, relieving swelling, promoting fluid production, and nourishing blood, and can be used for treating spleen deficiency spontaneous perspiration, middle-warmer energy sinking, exterior deficiency spontaneous perspiration, and qi deficiency water dampness edema. Radix Sophorae Flavescentis is bitter in taste and cold in nature, and has effects of clearing heat and eliminating dampness, and it enters heart, liver, stomach, large intestine and bladder channels. Radix Codonopsis is sweet in flavor and neutral in nature, has effects of invigorating spleen, benefiting lung, nourishing blood and promoting fluid production, and can be used for treating spleen-lung qi deficiency, anorexia and listlessness. The white atractylodes rhizome is bitter and sweet, is warm, enters spleen and stomach channels, has the effects of tonifying qi of spleen, eliminating dampness and promoting diuresis and stopping sweating, and is used for treating spleen deficiency-type food deficiency, abdominal distension and diarrhea, phlegm and fluid retention and palpitation. The white atractylodes rhizome is sweet and light in taste and neutral in nature, has the effects of promoting diuresis, excreting dampness, strengthening spleen and calming heart and is used for treating edema oliguria, phlegm and fluid retention, dizziness and palpitation, spleen deficiency and poor appetite, loose stool and diarrhea, uneasiness, palpitation and insomnia. Stir-baked Bai Zhu is good at invigorating spleen and tonifying kidney. The coix seed is sweet, bland and cool, and has the effects of promoting diuresis, excreting dampness, strengthening spleen and stopping diarrhea, and the coix seed enters spleen, stomach and lung channels. Stir-baked Yi ren is good at invigorating spleen and checking diarrhea. The oldenlandia diffusa is bitter and sweet in taste and cold in nature, enters stomach, large intestine and small intestine channels, has the functions of clearing heat, detoxifying and reducing swelling, and is widely used for treating various cancers. Tianlong is salty in taste, cold in nature and small in toxicity, and has the effects of tonifying heart and liver channels, dispelling wind, arresting convulsion, dredging collaterals, eliminating stagnation, and resolving hard mass. The centipede is pungent in taste and slightly warm in nature, enters liver and heart channels, has the effects of calming endogenous wind and relieving spasm, removing blood stasis and detoxifying, tonifying kidney and yang, and relieving pain, and plays a role in eliminating mass and relieving pain in tumor treatment. The liquorice has sweet taste and neutral nature, enters heart, lung, spleen and stomach channels, and has the effects of harmonizing the drugs in the recipe, reducing toxicity and relieving drug properties.
The recipe is mainly used for treating spleen qi deficiency, damp phlegm, heat and toxin, blood stasis and obstruction of collaterals type intestinal accumulation. In the formula, the astragalus is used as the monarch drug, the spleen and the stomach are used as the sources for the generation and transformation of qi and blood, and the astragalus is used for tonifying middle-jiao energy in the acquired origin to help the transportation and transformation of spleen qi, so that qi and blood are supplemented and viscera are nourished. Radix sophorae flavescentis, codonopsis pilosula, fried bighead atractylodes rhizome, white poria, fried semen coicis, oldenlandia diffusa, Gekko Swinhonis and centipede are used as ministerial drugs, and radix sophorae flavescentis and oldenlandia diffusa are used for clearing heat, removing toxicity and eliminating abdominal mass; the codonopsis pilosula strengthens spleen and lung, nourishes blood and promotes fluid production; the spleen prefers dryness and dislikes dampness, and the largehead atractylodes rhizome, the tuckahoe and the coix seed are used for tonifying spleen and replenishing qi, and promoting diuresis and excreting dampness; tianlong and Wu Gong are good in moving and flee, the insects and ants are taken to fly all the spirits quickly, the migrant lowers blood without coagulation, qi can be conducted, and the worms and ants attack and remove hard masses and have certain interval to the viscera, the insects and herbs have the properties of drilling, removing, searching and scraping, have no grass, wood and ore, and the efficacy of removing blood stasis in collaterals, removing toxicity and dissipating stagnation by pushing old. The liquorice is used as an adjuvant drug to coordinate the effects of the other drugs in the recipe. The whole formula is reviewed, the formula is rigorous, the materials are selected properly, the compatibility is reasonable, the medicine is simple and specific, and the effects of tonifying qi and spleen, dissipating stagnation and dredging collaterals are achieved together. Animal experiments and clinical experiments show that the formula for treating the colorectal cancer can obviously inhibit the growth of tumors, improve the survival rate, improve the health condition of patients and improve the life quality of the patients.
Compared with the traditional Chinese medicine composition disclosed in the earlier stage of the applicant, the traditional Chinese medicine composition disclosed by the invention is added with the tianlong and the centipedes, has the effects of calming endogenous wind and relieving convulsion, is added with the radix sophorae flavescentis, and has the effects of clearing heat and drying dampness, and is supplemented with the rest traditional Chinese medicines to achieve the synergistic effect, and the dosage of each medicine is proper, so that the curative effect is obviously improved, and the traditional Chinese medicine composition is superior to other traditional Chinese medicine compositions disclosed in the prior art. And the medicine does not need to be modified according to the symptoms of the patient with colorectal cancer, and is suitable for being developed into finished medicines.
Detailed Description
The following provides a detailed description of specific embodiments of the present invention.
Example 1 preparation of decoction of the Chinese medicinal composition of the present invention
Weighing the following raw material medicines in parts by weight: 25 parts of raw astragalus root, 18 parts of flavescent sophora root, 14 parts of pilose asiabell root, 20 parts of fried largehead atractylodes rhizome, 15 parts of white poria, 35 parts of fried coix seed, 25 parts of spreading hedyotis herb, 3 parts of dragon's blood, 1 part of centipede and 9 parts of liquorice, adding water, and decocting by a conventional method.
Example 2 preparation of decoction of the Chinese medicinal composition of the present invention
Weighing the following raw material medicines in parts by weight: 25 parts of raw astragalus root, 12 parts of flavescent sophora root, 16 parts of pilose asiabell root, 20 parts of fried largehead atractylodes rhizome, 15 parts of white poria, 25 parts of fried coix seed, 35 parts of spreading hedyotis herb, 3 parts of longhairy antenoron herb, 1 part of centipede and 3 parts of liquorice, adding water and decocting by a conventional method.
Example 3 preparation of decoction of the Chinese medicinal composition of the present invention (III)
Weighing the following raw material medicines in parts by weight: 25 parts of raw astragalus root, 12 parts of flavescent sophora root, 14 parts of pilose asiabell root, 20 parts of fried largehead atractylodes rhizome, 25 parts of white poria, 35 parts of fried coix seed, 25 parts of spreading hedyotis herb, 1 part of longhairy antenoron herb, 1 part of centipede and 9 parts of liquorice, adding water and decocting by a conventional method.
Example 4 preparation of decoction of the Chinese medicinal composition of the present Invention (IV)
Weighing the following raw material medicines in parts by weight: 25 parts of raw astragalus root, 12 parts of flavescent sophora root, 14 parts of pilose asiabell root, 15 parts of fried largehead atractylodes rhizome, 25 parts of white poria, 35 parts of fried coix seed, 35 parts of spreading hedyotis herb, 3 parts of dragon's bone, 1 part of centipede and 3 parts of liquorice, adding water and decocting by a conventional method.
Example 5 preparation of decoction of the Chinese medicinal composition of the present invention (V)
Weighing the following raw material medicines in parts by weight: 35 parts of raw astragalus root, 12 parts of flavescent sophora root, 16 parts of pilose asiabell root, 15 parts of fried largehead atractylodes rhizome, 25 parts of white poria, 25 parts of fried coix seed, 35 parts of spreading hedyotis herb, 1 part of longhairy antenoron herb, 3 parts of centipede and 3 parts of liquorice, adding water, and decocting by a conventional method.
Example 6 preparation of decoction of the Chinese medicinal composition of the present invention (six)
Weighing the following raw material medicines in parts by weight: 35 parts of raw astragalus root, 18 parts of flavescent sophora root, 14 parts of pilose asiabell root, 15 parts of fried largehead atractylodes rhizome, 25 parts of white poria, 35 parts of fried coix seed, 25 parts of spreading hedyotis herb, 1 part of longhairy antenoron herb, 3 parts of centipede and 9 parts of liquorice, adding water, and decocting by a conventional method.
Example 7 preparation of decoction of the Chinese medicinal composition of the present invention (seven)
Weighing the following raw material medicines in parts by weight: 35 parts of raw astragalus root, 18 parts of flavescent sophora root, 16 parts of pilose asiabell root, 15 parts of fried largehead atractylodes rhizome, 15 parts of white poria, 25 parts of fried coix seed, 35 parts of spreading hedyotis herb, 3 parts of longhairy antenoron herb, 3 parts of centipede and 3 parts of liquorice, adding water and decocting by a conventional method.
Example 8 preparation of decoction of the Chinese medicinal composition of the present invention (eight)
Weighing the following raw material medicines in parts by weight: 35 parts of raw astragalus root, 18 parts of flavescent sophora root, 16 parts of pilose asiabell root, 20 parts of fried largehead atractylodes rhizome, 15 parts of white poria, 25 parts of fried coix seed, 25 parts of spreading hedyotis herb, 1 part of longhairy antenoron herb, 3 parts of centipede and 9 parts of liquorice, adding water, and decocting by a conventional method.
Example 9 preparation of decoction of the Chinese medicinal composition of the present invention (nine)
Weighing the following raw material medicines in parts by weight: 28 parts of astragalus, 16 parts of sophora flavescens, 14 parts of codonopsis pilosula, 20 parts of fried bighead atractylodes rhizome, 17 parts of white poria, 32 parts of fried coix seed, 28 parts of oldenlandia diffusa, 3 parts of longsnout glorybower, 1 part of centipede and 6 parts of liquorice, and water is added for decoction by a conventional method.
Example 10 preparation of decoction of the Chinese medicinal composition of the present invention (ten)
Weighing the following raw material medicines in parts by weight: 32 parts of astragalus, 14 parts of sophora flavescens, 16 parts of codonopsis pilosula, 16 parts of fried bighead atractylodes rhizome, 22 parts of white poria, 28 parts of fried coix seed, 32 parts of spreading hedyotis herb, 1 part of longhairy antenoron herb, 3 parts of centipede and 3 parts of liquorice, and water is added for decoction by a conventional method.
Example 11 preparation of decoction of the Chinese medicinal composition of the present invention (eleven)
Weighing the following raw material medicines in parts by weight: 28 parts of astragalus, 14 parts of sophora flavescens, 16 parts of codonopsis pilosula, 20 parts of fried bighead atractylodes rhizome, 17 parts of white poria, 28 parts of fried coix seed, 32 parts of oldenlandia diffusa, 3 parts of longhairy antenoron, 1 part of centipede and 3 parts of liquorice, and water is added for decoction by a conventional method.
Example 12 preparation of decoction of the Chinese medicinal composition of the present invention (twelve)
Weighing the following raw material medicines in parts by weight: 32 parts of astragalus, 16 parts of sophora flavescens, 16 parts of codonopsis pilosula, 16 parts of fried bighead atractylodes rhizome, 17 parts of white poria, 28 parts of fried coix seed, 32 parts of oldenlandia diffusa, 3 parts of longhairy antenoron, 3 parts of centipede and 3 parts of liquorice, and water is added for decoction by a conventional method.
Example 13 preparation of decoction of the Chinese medicinal composition of the present invention (thirteen)
Weighing the following raw material medicines in parts by weight: 32 parts of astragalus, 16 parts of sophora flavescens, 16 parts of codonopsis pilosula, 20 parts of fried bighead atractylodes rhizome, 22 parts of white poria, 28 parts of fried coix seed, 28 parts of spreading hedyotis herb, 1 part of longhairy antenoron herb, 1 part of centipede and 3 parts of liquorice, and water is added for decoction by a conventional method.
Example 14 preparation of decoction of the Chinese medicinal composition of the present invention (fourteen)
Weighing the following raw material medicines in parts by weight: 32 parts of astragalus, 14 parts of sophora flavescens, 14 parts of codonopsis pilosula, 16 parts of fried bighead atractylodes rhizome, 17 parts of white poria, 28 parts of fried coix seed, 28 parts of oldenlandia diffusa, 1 part of longhairy antenoron herb, 1 part of centipede and 6 parts of liquorice, and water is added for decoction by a conventional method.
Example 15 preparation of decoction of the Chinese medicinal composition of the present invention (fifteen)
Weighing the following raw material medicines in parts by weight: 30 parts of astragalus, 15 parts of sophora flavescens, 15 parts of codonopsis pilosula, 18 parts of fried bighead atractylodes rhizome, 18 parts of white poria, 30 parts of fried coix seed, 30 parts of oldenlandia diffusa, 3 parts of longhairy antenoron, 1 part of centipede and 6 parts of liquorice, and water is added for decoction by a conventional method.
EXAMPLE 16 preparation of tablets/capsules of the Chinese medicinal composition of the present invention
The raw materials of the traditional Chinese medicine composition in any one of the embodiments 1 to 15 are taken, water with the amount of 8 to 10 times of the raw materials is added, the decoction is decocted for 1 to 3 hours, and the decoction is filtered. Adding 10 times of water, decocting for 1.5-2.5 hr, filtering to obtain decoction, mixing decoctions, standing, filtering to obtain supernatant, concentrating, cooling, adding 2.5 times of ethanol, stirring, and precipitating overnight. Taking supernatant, and concentrating to obtain thick extract; adding pharmaceutical adjuvants, vacuum drying, pulverizing, granulating, and making into tablet or capsule.
Example 17 preparation of granules of the Chinese medicinal composition of the present invention
The raw materials of the traditional Chinese medicine composition in any one of the embodiments 1 to 15 are taken, 8 to 12 times of water is added, the decoction is carried out for 2.5 to 3.5 hours, and the medicine juice is filtered. Adding 10 times of water, decocting for 2 hours, filtering out the decoction, combining the two decoctions, standing, filtering to obtain the supernatant, concentrating, cooling, adding 2 times of alcohol, stirring and precipitating overnight. Taking supernatant, and concentrating to obtain thick extract; adding appropriate pharmaceutical adjuvants, granulating, drying, grading to obtain 20g granule, and packaging into 10 g/bag.
EXAMPLE 18 preparation of a combination of Chinese medicinal compositions of the present invention
The raw materials of the traditional Chinese medicine composition in any one of the embodiments 1 to 15 are taken, water with the amount of 8 to 10 times of the raw materials is added, the decoction is decocted for 3 hours, and the decoction is filtered. Adding 8 times of water, decocting for 2 hours, filtering out the decoction, combining the two decoctions, standing, filtering to obtain the supernatant, concentrating, cooling, adding 2 times of alcohol, stirring and precipitating overnight. Taking supernatant, and concentrating to obtain thick extract; adding appropriate pharmaceutical adjuvants, and making into mixture.
Example 19 animal experiment of the Chinese medicinal composition of the present invention for treating colorectal cancer
1 materials and methods
1.1 cell lines
The HT-29 cell line for human colon cancer was purchased from the Shanghai cell institute of Chinese academy of sciences.
1.2 animals
BALB/c nude mice, 4-6 weeks old, male, body mass (18 + -2) g, SPF grade, purchased from Shanghai Si Laike laboratory animals, Inc.
1.3 drugs
Medicine 1: 30 parts of astragalus, 15 parts of sophora flavescens, 15 parts of codonopsis pilosula, 18 parts of fried bighead atractylodes rhizome, 18 parts of white poria, 30 parts of fried semen coicis, 30 parts of oldenlandia diffusa, 3 parts of longhairy antenoron, 1 part of centipede and 6 parts of liquorice, and the mixture is prepared into a decoction containing 3g of crude drugs per milliliter by a conventional decoction method;
medicine 2: 30 parts of astragalus, 22 parts of sophora flavescens, 15 parts of codonopsis pilosula, 18 parts of fried bighead atractylodes rhizome, 18 parts of white poria, 30 parts of fried coix seed, 30 parts of oldenlandia diffusa, 3 parts of longhairy antenoron, 1 part of centipede and 6 parts of liquorice, and the mixture is prepared into a decoction containing 3g of crude drugs per milliliter by a conventional decoction method;
medicine 3: 30 parts of astragalus, 15 parts of sophora flavescens, 15 parts of codonopsis pilosula, 18 parts of fried bighead atractylodes rhizome, 18 parts of white poria, 30 parts of fried coix seed, 30 parts of oldenlandia diffusa, 3 parts of longhairy antenoron, 1 part of raw oyster and 6 parts of liquorice, and the mixture is prepared into a decoction containing 3g of crude drugs per milliliter by a conventional decoction method;
medicine 4: 15 parts of codonopsis pilosula, 30 parts of astragalus, 18 parts of fried bighead atractylodes rhizome, 15 parts of epimedium, 30 parts of fried rice kernels, 9 parts of pinellia ternate, 15 parts of dandelion, 15 parts of raw oyster, 15 parts of curcuma zedoary and 30 parts of Chinese actinidia roots, and the raw materials are prepared into a decoction containing 3g of crude drugs per milliliter by a conventional decoction method;
5, medicine: 15 parts of codonopsis pilosula, 30 parts of astragalus, 15 parts of bighead atractylodes rhizome, 15 parts of fiveleaf akebia fruit, 30 parts of poria cocos, 30 parts of semen coicis, 30 parts of chinaroot greenbrier, 30 parts of curcuma zedoary, 15 parts of radix curcumae, 30 parts of rhizoma smilacis glabrae, 30 parts of amur grape vine, 2 parts of centipede, 6 parts of dragon, 30 parts of calcined corrugate rhizome, 12 parts of muskroot fruit, 30 parts of rhizoma polygonati, 15 parts of cornus officinalis, 15 parts of herba epimedii and 15 parts of semen cuscutae, and the traditional Chinese medicine is prepared by a conventional decoction method to contain 3g of crude drugs per milliliter;
5-Fluorouracil (5-FU) was purchased from Sigma.
1.4 methods
1.4.1 human intestinal cancer cell culture
Human colon cancer HT-29 cells are cultured in RPMI-1640 medium containing 10% fetal calf serum, 1.5g/L sodium bicarbonate, and 1.5mmol/L glutamine at 37 deg.C under 5% CO2Cultured in an incubator.
1.4.2 establishment of nude mouse model of human intestinal cancer subcutaneous transplantation tumor and its group administration
According to the literature (Liu Xuan, Lihua, Yinpeihao, etc. spleen-invigorating detoxification prescription for inhibiting angiogenesis of human intestinal cancer in nude mice [ J)]Chinese medical science, 2013, 3 (3): 23-25/36.) methods for establishing human intestinal cancerHT-29 cell subcutaneous transplantation tumor model. When the tumor grows to 100-300mm3Animals were randomized into 7 groups of 10 animals each: (1) model group (saline group); (2) drug 1 group (0.5 mL/d); (3) drug 2 group (0.5 mL/d); (4) drug 3 group (0.5 mL/d); (5) drug 4 group (0.5 mL/d); (6) drug 5 group (0.5 mL/d); (7)5-FU group (1 mg/(kg. multidot.2d)). The medicine 1 to 5 groups are administered by intragastric administration every day, 5-FU is administered by intraperitoneal injection every other day, and the model group is administered by intragastric administration of physiological saline with the same amount every day. Mice were sacrificed on day 21 of administration, tumor bodies were removed, and tumor body mass was measured. Tumor weight inhibition rate ═ l-mean tumor weight in experimental group/mean tumor weight in control group x 100%.
1.5 statistical analysis
Statistical analysis of tumor mass for each group was performed using SPSS 20.0. The measured data are tested by t test, and the difference is that P is less than 0.05, which has statistical significance.
2 results
The statistical results of the tumor body mass and the tumor inhibition rate of each group are shown in Table 1. Compared with a model group, the tumor body quality of each treatment group is obviously reduced, and the difference has statistical significance, which shows that the tumor inhibiting effect is better. The tumor mass of the drug 1 group is obviously lower than that of the drug 2 group to the drug 5 group, the difference has statistical significance, and compared with the 5-FU group, the difference has no statistical difference, which shows that the tumor inhibition effect of the drug has advantages compared with other traditional Chinese medicines.
TABLE 1 tumor body mass and tumor inhibition rate of each group
Note: comparing with model group, P is less than 0.01; compared with the drug 1 group, #, P <0.05, #, P < 0.01.
Example 20 clinical experiments on treatment of colorectal cancer with the Chinese medicinal composition of the present invention
1 study object
1.1 case selection
All cases come from Shanghai city traditional Chinese medicine hospitals, the case collection time is from 2012 to 2016 to 4 months, and postoperative colorectal cancer cases are collected.
1.2 diagnostic criteria
1.2.1 Western diagnostic standards
Colorectal cancer patients with definite pathological and cytological diagnosis (diagnosis standard is according to China general malignant tumor diagnosis and treatment standard compiled by medical government department of the Ministry of public health of the people's republic of China). Clinical staging standard: TNM staging of colorectal cancer according to the new revision of the international association for anticancer (UICC) 1997.
1.2.2 Chinese medicine syndrome diagnostic standard
According to the guiding principle of clinical research of new traditional Chinese medicines and the routine diagnosis and treatment of traditional Chinese medicine diseases in Shanghai City, the patients with spleen deficiency syndrome are determined as the entry standard by combining clinical experience. The main symptoms are: weakness, poor appetite, abdominal distension, unsmooth defecation, enlarged tongue with teeth marks, thin and white coating, thready pulse and the like.
1.3 inclusion criteria
(1) The colorectal cancer which has been subjected to radical treatment in the past has definite pathological diagnosis after operation.
(2) According with the diagnosis standards, the pathological stage is as follows: TNM staging patients in stages I-III.
(3) No anti-tumor treatment or other drugs affecting the observed results were taken 6 months before the test.
(4) The age is more than or equal to 18 years old, and the nature is not limited. Karnofsky score of more than 60 points, and expected survival time of more than 3 months.
(5) Without severe center of gravity, liver, kidney, hematopoietic system diseases and other factors affecting drug evaluation.
(6) The situation of the trial was understood and the informed consenter was signed.
1.4 exclusion criteria
(1) Those that do not meet the inclusion criteria.
(2) Patients with obvious damage to heart, liver, kidney or hematopoietic function, or mental patients, pregnant women or lactating women.
(3) Are participating in other drug trials.
(4) If the drug is not administered as specified or the data is not complete.
(5) Researchers considered it inappropriate to participate in this trial.
1.5 case knockout and shedding criteria
(1) Those who did not comply with the protocol were found after enrollment.
(2) After the treatment, severe body diseases are found.
(3) < 80%, > 120%, patients not taking the drug according to the schedule.
(4) Due to adverse events, patient visits, lack of efficacy, patient active withdrawal of informed consent, etc.
1.6 test standards for discontinuation
(1) Those with severe adverse events or severe adverse reactions.
(2) Other serious complications occur during clinical trials.
(3) The patient's condition deterioration must be treated by emergency treatment.
(4) The patients who receive the treatment such as targeting and radiotherapy during the treatment period.
2 method
2.1 test drugs
The first traditional Chinese medicine: decoction is prepared according to the method of example 15, the medicine composition is: 30 parts of astragalus, 15 parts of sophora flavescens, 15 parts of codonopsis pilosula, 18 parts of fried bighead atractylodes rhizome, 18 parts of white poria, 30 parts of fried coix seed, 30 parts of oldenlandia diffusa, 3 parts of longhairy antenoron herb, 1 part of centipede and 6 parts of liquorice. The decoction crude drug content is 0.12 g/ml.
B, traditional Chinese medicine II: the decoction is prepared according to the formula of CN105456949A, and the medicine composition is as follows: 15 parts of codonopsis pilosula, 30 parts of astragalus membranaceus, 18 parts of fried bighead atractylodes rhizome, 15 parts of epimedium herb, 30 parts of fried rice kernels, 9 parts of pinellia ternate, 15 parts of dandelion, 15 parts of raw oyster, 15 parts of curcuma zedoary and 30 parts of Chinese actinidia root. The decoction crude drug content is 0.12 g/ml.
And C, Chinese medicine III: the decoction is prepared according to the formula of a literature (horse courser, royal Ye, Chua Difang, and the like, clinical observation of a spleen-tonifying and tumor-eliminating prescription for preventing postoperative metastasis and recurrence of colorectal cancer, Shanghai medical journal (2005, No. 01)), and the medicine composition is as follows: 15 parts of codonopsis pilosula, 30 parts of astragalus membranaceus, 15 parts of bighead atractylodes rhizome, 15 parts of fiveleaf akebia fruit, 30 parts of poria cocos, 30 parts of semen coicis, 30 parts of chinaroot greenbrier, 30 parts of curcuma zedoary, 15 parts of radix curcumae, 30 parts of rhizoma smilacis glabrae, 30 parts of amur grape vine, 2 parts of centipede, 6 parts of dragon's blood, 30 parts of calcined corrugated container, 12 parts of radix semiaquilegiae, 30 parts of rhizoma polygonati, 15 parts of cornus officinalis, 15 parts of herba epimedii and 15 parts of semen cuscutae.
2.2 grouping method
Designing a randomization scheme, manufacturing a random envelope, hiding the random scheme, and randomly dividing patients brought into the study into four groups, namely a chemotherapy group, a traditional Chinese medicine one + chemotherapy group, a traditional Chinese medicine two + chemotherapy group and a traditional Chinese medicine three + chemotherapy group.
2.3 methods of treatment
Chemotherapy groups: according to the international tumor postoperative chemotherapy rule, 6 courses of chemotherapy are performed after the operation. Chemotherapy was performed according to the colorectal cancer NCCN guidelines using the commonly used FOLFIRI, XELOX, FOLFOX4, FOLFOX6 regimen as follows: FOLFIRI protocol (irinotecan 180mg/m2 quiet drop d1, calcium folinate 400mg/m2 quiet drop d1, 5-fluorouracil 400mg/m2 quiet push d1, followed by 2400mg/m2 maintenance quiet push 46h, 1 cycle per 14 d); the XELOX regimen (oxaliplatin 130mg/m2 intravenous d1, capecitabine 1250mg/m 22 times daily, oral d1-14, 1 cycle per 21 d); FOLFOX4 regimen (oxaliplatin 85mg/m 2D 1, calcium folinate 200mg/m 2D 1-2, 5-fluorouracil 400mg/m2 static push d1-2, 5-fluorouracil 600mg/m2 maintenance static push 22hd1-2, 1 cycle per 14 d); FOLFOX6 protocol (oxaliplatin 85mg/m 2d 1, calcium folinate 400mg/m 2d 1, 5-fluorouracil 400mg/m2 static push d1, 5-fluorouracil 2400mg/m2 maintenance static drop 46h, 1 cycle per 14 d).
Traditional Chinese medicine I + chemotherapy group: the chemotherapy scheme is the same as chemotherapy group, and the first Chinese medicine is decocted to prepare decoction with crude drug content of 0.12g/ml, and 200ml is taken in the morning and at night.
Traditional Chinese medicine II + chemotherapy group: the chemotherapy scheme is the same as that of the chemotherapy group, and the traditional Chinese medicine II is decocted to prepare decoction with the crude drug content of 0.12g/ml, and 200ml of the decoction is taken warmly in the morning and at night.
Traditional Chinese medicine three + chemotherapy group: the chemotherapy scheme is the same as chemotherapy group, and the three traditional Chinese medicines are decocted to prepare decoction with crude drug content of 0.12g/ml, and 200ml is taken warmly in the morning and at night.
2.4 evaluation of therapeutic Effect
2.4.1 statistical survival
And (5) counting the survival rate of each group.
2.4.2 card Scoring
And scoring the physical condition of the patient according to the card type scoring standard.
2.4.3 statistics of total effective rate of tumor body curative effect
RECIST1.1 solid tumor curative effect evaluation criteria are adopted, and the curative effect evaluation criteria are as follows:
complete Remission (CR): complete disappearance of lesions is seen for more than 4 weeks;
partial Remission (PR): shrinkage of 30% and more than 4 weeks;
stable (SD, NC): non-PR/PD;
progression (PD): increase 20%, pre-lesion increase non-CR/PR/SD;
total effective rate (ORR) ═ CR + PR;
disease Control Rate (DCR) ═ CR + PR + SD.
2.5 statistical analysis
The statistical method uses SPSS 20.0 to perform statistical analysis on the survival time, card type score and total effective rate of each group. The metering data adopts t inspection; the data of the counting is as follows2And (4) testing, wherein the Wilcoxon rank sum test is adopted for the grade data. The difference is statistically significant when P is less than 0.05.
3 results
3.1 case data
After the clinical trial was completed, the cases of the groups eventually included data statistics are shown in table 2. Wherein, the data of each group of cases in terms of age, sex, clinical stage, lesion part and the like are basically consistent and have comparability.
TABLE 2 basic data of each group of cases
3.2 survival rates of groups
The statistical results of the survival rates of the groups are shown in Table 3. Compared with the chemotherapy group, the traditional Chinese medicine treatment group is beneficial to improving the survival rate, and the effect of the first traditional Chinese medicine is most obvious.
Table 3 survival rate (%)
Note: p <0.05 compared to chemotherapy group; compared with the group treated by the first Chinese medicine and the chemotherapy, the P is less than 0.05.
3.3 Each group of card scores
Evaluation was performed according to the Karnofsky criteria. The improvement is as follows: the score is improved by 10 points or more after treatment; and (3) reducing: a reduction in score by 10 points or more after treatment; and (3) stabilizing: the score increased or decreased by less than 10 points after treatment. The results (table 4) show that the traditional Chinese medicine group I plus chemotherapy group can significantly improve the KPS scores of most patients and improve the health conditions of the patients.
TABLE 4 KPS scores for each group
3.4 Total effective rate of tumor curative effect of each group
The statistical results of the total effective rate of the tumor curative effect of each group are shown in table 5. Compared with the chemotherapy group, the total effective rate of the tumor curative effect of each traditional Chinese medicine treatment group is improved, wherein the total effective rate of the tumor curative effect of the first traditional Chinese medicine treatment group and the chemotherapy group is obviously higher than that of the other groups (P is less than 0.05).
TABLE 5 curative effect of tumor body
The above description is only a preferred embodiment of the present invention, and it should be noted that, for those skilled in the art, several modifications and additions can be made without departing from the method of the present invention, and these modifications and additions should also be regarded as the protection scope of the present invention.
Claims (8)
1. The traditional Chinese medicine composition for treating colorectal cancer is characterized by being prepared from the following raw material medicines in parts by weight: 25-35 parts of raw astragalus root, 12-18 parts of sophora flavescens, 14-16 parts of codonopsis pilosula, 15-20 parts of fried bighead atractylodes rhizome, 15-25 parts of white poria, 25-35 parts of fried coix seed, 25-35 parts of spreading hedyotis herb, 1-3 parts of dragon's bone, 1-3 parts of centipede and 3-9 parts of liquorice.
2. The traditional Chinese medicine composition according to claim 1, which is prepared from the following raw materials in parts by weight: 28-32 parts of raw astragalus, 14-16 parts of radix sophorae flavescentis, 14-16 parts of codonopsis pilosula, 16-20 parts of fried bighead atractylodes rhizome, 17-22 parts of white poria, 28-32 parts of fried coix seed, 28-32 parts of spreading hedyotis herb, 1-3 parts of dragon's bone, 1-3 parts of centipede and 3-6 parts of liquorice.
3. The traditional Chinese medicine composition according to claim 2, which is prepared from the following raw materials in parts by weight: 30 parts of raw astragalus, 15 parts of radix sophorae flavescentis, 15 parts of codonopsis pilosula, 18 parts of fried bighead atractylodes rhizome, 18 parts of white poria, 30 parts of fried semen coicis, 30 parts of oldenlandia diffusa, 3 parts of longhairy antenoron herb, 1 part of centipede and 6 parts of liquorice.
4. The traditional Chinese medicine composition of claim 1, wherein the dosage form of the traditional Chinese medicine composition is decoction, capsule, granule, tablet or mixture.
5. The traditional Chinese medicine composition of claim 1, wherein the traditional Chinese medicine composition further comprises a pharmaceutically acceptable carrier.
6. Use of a Chinese medicinal composition as claimed in any one of claims 1 to 5 in the manufacture of a medicament for the treatment of colorectal cancer.
7. The use according to claim 6, wherein the colon cancer is post-operative colon cancer.
8. The preparation method of the traditional Chinese medicine composition of any one of claims 1 to 5, which is characterized by comprising the following steps:
preparation of the decoction: weighing the raw materials in parts by weight, adding water, and decocting by a conventional method to prepare decoction;
preparation of tablets or capsules: weighing the raw materials according to the weight parts, adding 8-10 times of water, decocting for 1-3 hours, and filtering out medicine juice; adding 10 times of water, decocting for 1.5-2.5 hr, filtering to obtain decoction, mixing decoctions, standing, filtering to obtain supernatant, concentrating, cooling, adding 2.5 times of ethanol, stirring, and precipitating overnight; taking supernatant, and concentrating to obtain thick extract; adding pharmaceutical adjuvants, vacuum drying, pulverizing, granulating, and making into tablet or capsule;
preparation of granules: weighing the raw materials according to the weight parts, adding 8-12 times of water, decocting for 2.5-3.5 hours, and filtering out medicine juice; adding 10 times of water, decocting for 2 hours, filtering out the decoction, mixing the two decoctions, standing, filtering to obtain the supernatant, concentrating, cooling, adding 2 times of alcohol, stirring and precipitating overnight; taking supernatant, and concentrating to obtain thick extract; adding appropriate pharmaceutical adjuvants, granulating, drying, grading, and making into granule;
preparation of the mixture: weighing the raw materials according to the weight parts, adding 8-10 times of water, decocting for 3 hours, and filtering out medicine juice; adding 8 times of water, decocting for 2 hours, filtering out the decoction, mixing the two decoctions, standing, filtering to obtain the supernatant, concentrating, cooling, adding 2 times of alcohol, stirring and precipitating overnight; taking supernatant, and concentrating to obtain thick extract; adding appropriate pharmaceutical adjuvants, and making into mixture.
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